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AzTrials

AsthmaPhase 3NCT01686633

An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.

A Phase 3 study testing Fluticasone Furoate/ Vilanterol 200/25 mcg, Fluticasone Furoate/ Vilanterol 100/25 mcg and Fluticasone Furoate 100 mcg in people with Asthma, run by GlaxoSmithKline at 136 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Fluticasone Furoate/ Vilanterol 200/25 mcg, Fluticasone Furoate/ Vilanterol 100/25 mcg and Fluticasone Furoate 100 mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,040 participants
Where
136 sitesin 11 countries
Study dates
20 Sep 2012to 15 Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects must give their signed and dated (written) informed consent to participate. Written informed consent must be obtained if a subject's current medication is changed as a result of study participation
  • Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects >=18 years of age
  • Male or an eligible female. Eligible female is defined as having non-childbearing potential or having childbearing potential and using an acceptable method of birth control consistently and correctly.
  • Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value.
  • Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required.
  • If subject have received ICS for at least 12 weeks prior to Visit 1 and their treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., >=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g., FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate inhalers.
  • Use of ICS/LABA are not permitted with LABA on the day of Visit 1.
  • Must be able to replace current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, during the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits

Who cannot join

  • History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
  • Upper or lower respiratory tract, sinus, or middle ear that is: not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Any asthma exacerbation that required oral corticosteroids within the 12 weeks prior to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
  • A subject must not have current evidence of atelectasis (segmental or larger), bronchopulmonary dysplasia, chronic obstructive pulmonary disease, Or any evidence of concurrent respiratory disease other than asthma
  • A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study
  • Chronic stable hepatitis B or C are acceptable provided their screening alanine transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible
Show all 18Show fewer
  • Clinical visual evidence of candidiasis at Visit 1
  • Use of any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½), whichever is longer of the two.
  • Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy
  • Administration of medication that would significantly affect the course of asthma, or interact with study drug
  • Use of immunosuppressive medications during the study.
  • Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1.
  • A subject or his/her parent or legal guardian has any infirmity, disability, disease, or resides in a geographical location which seems likely, in the opinion of the Investigator, to impair compliance with any aspect of this study protocol, including visit schedule, and completion of the daily diaries.
  • Current smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, or pipe tobacco).
  • If subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • Subject previously randomized to treatment with FF/VI or FF in another Phase III study
  • Subjects working on night shift a week prior to Visit 1 or during the study period.
  • Adolescents who are wards of the state or government

Trial locations and contacts

136 sites in 11 countries.

136 sites in 11 countries

United States37 sites

  • GSK Investigational Site

    Bethesda, Maryland, 20814

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    El Paso, Texas, 79903

  • GSK Investigational Site

    Fort Mill, South Carolina, 29707

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Middleburg Heights, Ohio, 44130

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Richmond, Virginia, 23219

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    San Diego, California, 92103-8415

  • GSK Investigational Site

    Seattle, Washington, 98122

  • GSK Investigational Site

    Shelby, North Carolina, 28152

  • GSK Investigational Site

    Skillman, New Jersey, 08558

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63143

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

Other trials in United States

Russia19 sites

  • GSK Investigational Site

    Blagoveshchensk, 675000

  • GSK Investigational Site

    Chelyabinsk, 454021

  • GSK Investigational Site

    Chita, 672090

  • GSK Investigational Site

    Ivanovo, 153005

  • GSK Investigational Site

    Kazan', 420015

  • GSK Investigational Site

    Moscow, 115446

  • GSK Investigational Site

    Moscow, 123182

  • GSK Investigational Site

    Moscow, 123367

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Pyatigorsk, 357538

  • GSK Investigational Site

    Ryazan, 390039

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Stavropol, 355030

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Vladivostok, 690950

  • GSK Investigational Site

    Voronezh, 394066

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Romania13 sites

  • GSK Investigational Site

    Bacau, 600114

  • GSK Investigational Site

    Brasov, 500112

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 022102

  • GSK Investigational Site

    Bucharest, 030317

  • GSK Investigational Site

    Cluj-Napoca, 400370

  • GSK Investigational Site

    Craiova, 200642

  • GSK Investigational Site

    Deva, 330084

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Piteşti, 110084

  • GSK Investigational Site

    Ploieşti, 100172

  • GSK Investigational Site

    Ploieşti, 100184

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Argentina12 sites

  • GSK Investigational Site

    Berazategui, 1886

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1425FVH

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Nueve de Julio, Buenos Aires, B6500BWQ

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000JKR

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

Other trials in Argentina

Germany12 sites

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Berlin, 14050

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Potsdam, Brandenburg, 14467

Other trials in Germany

Ukraine12 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49051

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Kyiv, 04201

  • GSK Investigational Site

    Poltava, 36024

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Zaporizhia, 69035

  • GSK Investigational Site

    Zaporizhia, 69063

  • GSK Investigational Site

    Zaporizhia, 69076

Other trials in Ukraine

Poland8 sites

  • GSK Investigational Site

    Bialystok, 15-027

  • GSK Investigational Site

    Krakow, 30-901

  • GSK Investigational Site

    Krakow, 31-024

  • GSK Investigational Site

    Krakow, 31-455

  • GSK Investigational Site

    Lodz, 90-242

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Warsaw, 02-507

  • GSK Investigational Site

    Wroclaw, 53-301

Other trials in Poland

Chile7 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Quillota, Valparaiso, 2260000

  • GSK Investigational Site

    Rancagua, Reg Del Libert Bern Ohiggins, 2841959

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500800

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

  • GSK Investigational Site

    Viña del Mar, Valparaiso

Other trials in Chile

Netherlands7 sites

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Enschede, 7513 ER

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Veldhoven, 5504 DB

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Sweden5 sites

  • GSK Investigational Site

    Gothenburg, SE-413 90

  • GSK Investigational Site

    Linköping, SE-582 16

  • GSK Investigational Site

    Luleå, SE-971 89

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Mexico4 sites

  • GSK Investigational Site

    Monterrey, Nuevo León, 64000

  • GSK Investigational Site

    Morelia, Michoacán, 58070

  • GSK Investigational Site

    Villahermosa, Tabasco, 86100

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents

This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).

Conditions
Asthma
Being tested
Fluticasone Furoate/ Vilanterol 200/25 mcg, Fluticasone Furoate/ Vilanterol 100/25 mcg, Fluticasone Furoate 100 mcg
Keywords
asthma, pharmacogenetics, adult, vilanterol, adolescents, fluticasone furoate
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone Furoate/ Vilanterol 200/25 mcgDrug

    Fluticasone furoate/ vilanterol will be available as 200/25 mcg Novel dry powder inhaler (NDPI) with 30 doses per device and 200/25 mcg per actuation

  • Fluticasone Furoate/ Vilanterol 100/25 mcgDrug

    Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

  • Fluticasone Furoate 100 mcgDrug

    Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

Study groups in NCT01686633
Study groupRoleWhat they receive
Arm1: Fluticasone Furoate/ Vilanterol 200/25 mcgExperimentalAt Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (<=65% or >65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 200/25 mcg once daily in the evening for 84 days.
Receives: Drug: Fluticasone Furoate/ Vilanterol 200/25 mcg
Arm 2: Fluticasone Furoate/ Vilanterol 100/25 mcgExperimentalAt Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (<=65% or >65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 100/25 mcg once daily in the evening for 84 days
Receives: Drug: Fluticasone Furoate/ Vilanterol 100/25 mcg
Arm 3: Fluticasone Furoate 100 mcgExperimentalAt Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (<=65% or >65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF 100 mcg once daily in the evening for 84 days
Receives: Drug: Fluticasone Furoate 100 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period

    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.

    Measured: Baseline and Week 12

Secondary outcomes (5)

  1. Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period

    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.

    Measured: Baseline and Week 12

  2. Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period

    The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

    Measured: Baseline and Weeks 1-12

  3. Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period

    Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

    Measured: Baseline and Weeks 1-12

  4. Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period

    Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

    Measured: Baseline and Weeks 1-12

  5. Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period

    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

    Measured: Baseline and Weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2012 (estimated)
  2. Study start20 Sep 2012
  3. Primary completion1 Oct 2013
  4. Study completion15 Oct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,040 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01686633
Sponsor's protocol ID
116863
Status last verified
Jan 2018
First submitted
13 Sep 2012
Last updated
24 Jan 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PubMed 36472162

  • Bernstein DI, Bateman ED, Woodcock A, Toler WT, Forth R, Jacques L, Nunn C, O'Byrne PM. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2015;52(10):1073-83. doi: 10.3109/02770903.2015.1056350. Epub 2015 Aug 18.

    PubMed 26291137

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate/ Vilanterol 200/25 mcg, Fluticasone Furoate/ Vilanterol 100/25 mcg and Fluticasone Furoate 100 mcg in people with Asthma, run by GlaxoSmithKline at 136 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, Russia, Romania, Argentina, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01686633, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.

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